United States: More From The Mirena IIH Daubert Decision

A couple of weeks ago, we
reported on the terrific Daubert decision in the
Mirena IIH MDL in the Southern District of New York,
In re Mirena IUS Levonorgestrel-Related Prods. Liab.
Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), in which the
court granted the defendants' motions to dismiss all seven of
the plaintiffs' remaining general causation experts. In that
post, we explained that all seven opined that the defendants'
intrauterine contraceptive device caused idiopathic intracranial
hypertension ("IIH"), a rare and potentially serious
condition market by increased cerebrospinal pressure in the skull.
Only one study had ever found a causal link between Mirena and IIH.
That study was by Dr. Mahyar Etminan, who was on the
plaintiffs' payroll at the time he published the study, a fact
he failed to disclose. After a prominent scientist in the field
attacked the methodology of the Etminan study because it failed to
control for age and gender, Dr. Etminan repudiated much of the
study's analysis and withdrew as an expert.

Of the seven remaining experts, four drew their general
causation conclusions largely by drawing on existing sources,
including varying combinations of case reports regarding Mirena,
case reports regarding other contraceptive products containing LNG,
another product's warning label, the repudiated portions of the
Etminan study, and another study (the "Valenzuela study")
that reported a statistically significant association between
LNG-containing devices and IIH but which, the authors emphasized,
found only a correlation, not a causal link. The other three
experts were "mechanism" experts, each of whom postulated
a supposed mechanism by which the defendant's product could
cause IIH. In our last post, we reported on the court's
decisions regarding two of the experts in the first group but we
promised to tell you more. Today, we focus on one more expert in
that group as well as highlights of the court's decisions about
the "mechanism" experts.

The former, the plaintiffs' ophthalmology expert, was the
only one of the plaintiffs' experts who had written about the
relationship between levonorgestrel ("LNG"), the
synthetic hormone in the defendants' contraceptive device, and
IIH, and was the only one of the plaintiffs' experts who had
written an expert report on the supposed causal link before the MDL
was formed. In a 2015 book about drug-induced ocular side effects,
the expert had stated that he believed there was a
"possible," but not a "probable," association
between LNG and IIH. In the book, he explained that he assessed
causation as possible "when there is a temporal relationship,
but the association could also be explained by concurrent disease
or other drugs or chemicals," and dechallenge data
(information about what happens when the treatment is withdrawn) is
"lacking or unclear." Mirena, 2018 WL 5276431 at
*47 (citation omitted). In contrast, causation is
"probable" or "likely" when "there is a
temporal relationship unlikely to be attributed to a concurrent
disease or drugs" and there is positive dechallenge data.
Id. The book's conclusion that there was a
"possible" causal association between LNG and IIH was
based largely on case reports involving the defendants' product
and other LNG-containing products and upon two publications
discussing several of those case reports. The book did not consider
the Etminan and Valenzuela studies, which had not yet been
published.

Unlike the other experts in the first group, the ophthalmologist
did not claim to have performed a Bradford Hill analysis. Instead,
in support of the expert's causation conclusion, his report
cited case reports, discussion of another LNG-containing product,
case reports, and citations to both the Etminan and Valenzuela
studies. In addition, the report included a vague discussion of
broad propositions from which he suggested that there was a
biological mechanism for LNG to cause IIH. In his deposition,
however, he repudiated this "mechanism" opinion,
testifying that the mechanism was "unknown" and that he
was not being offered as a "mechanism" expert.

Analyzing the expert's opinion, the court stated,
"[The] proposed testimony amounts to a blend of disparate
items that [the expert] contents together show that Mirena causes
IIH. . . . [The expert] does not purport to use the flexible
Bradford Hill methodology to guide his analysis." Instead, he
used a "non-replicable mode of analysis" consisting of
"listing factors that he argues support his conclusion."
Id. at *50. The court held that the expert's proposed
testimony "fails to meet any of the Daubert
reliability factors." The expert's causation conclusion
"has not been tested; it has not been subject to peer review;
it has no known error rate and there are no standards controlling
its operation; and it has not been generally accepted by the
scientific community." Moreover, the expert's
"handling of virtually every one of the individual items on
which he relies" was "methodologically suspect."
Id. This included overlooking the fatal flaws in the
Etminan study, the expert's failure "to engage with
consequential evidence contrary to his outcome." Id.
at *51-52. Finally, though the expert "[made] his mechanism
opinion an important component of his expert report," he
"repeatedly distanced himself" from that opinion at his
deposition, "repudiate[ing] any mechanism opinion as beyond
his expertise." The court held, ""The removal of
that pillar alone is fatal to [the expert's] weight of the
evidence analysis;" moreover, the "mechanism"
opinion would have been inadmissible in any event because the
expert was not qualified to offer it. Id. at *52. And so,
holding that the expert's opinions failed to satisfy
Daubert's reliability standards, the court excluded
the opinions in their entirety.

The plaintiffs' "mechanism" experts fared no
better. One, an OB/GYN and the founder of a clinical and
epidemiological research organization devoted to reproductive
health issues, "embrace[d] the 'androgen theory' by
which Mirena purportedly causes IIH—specifically that
androgens cause IIH and that because LNG, while a progestin, has
androgenic effects, LNG in turn may cause IIH." Id.
at *53. The court held, "As a threshold consideration, [the]
theory that Mirena causes IIH through androgenic side effects does
not satisfy any of the four Daubert reliability
factors." Id. at *58. But beyond the flaws in the
opinion's premises, the court "discern[ed] a broader
overarching lapse of methodology" affecting the mechanism
opinion: the expert's report did not address the threshold
issue of "what IIH is and how this condition comes
about." Id. In addition, the court criticized (in
extensive and thorough detail that is beyond the capacity of these
pages) the expert's "scant attention to the
pharmacokinetic process that must underlie the causal sequence that
he postulates" and his "speculative leaps in support of
his two central premises: that androgens can cause IIH, and that
LNG, a progestin with androgen receptor affinity, can cause
IIH." Id. The court concluded,

"In the end, while [the
expert's] credentials are sterling, the methodology underlying
his opinion in this case is not. He relies on supposition and
attempts to link disconnected studies by others. And he uses some
of his source material for more than it can fairly support. The
result is a hypothesis that may or may not bear up when and if it
is ultimately tested, not a reliable expert opinion admissible
under the governing standards. The Court therefore must exclude his
testimony." Id. at *62.

The court similarly dispatched the plaintiffs' other two
mechanism experts because their methodologies were unsound and
their theories failed to satisfy Daubert's reliability
standards. Both discussions are lengthy and we cannot do justice to
them here, but we again recommend that you read the whole opinion
when you have time to appreciate its rigor and its unflinching
confrontation and dissection of the technicalities underlying all
of the experts' opinions. Doing justice to Daubert analysis of
opinions like these is a monumental task. All too frequently, and
perhaps understandably, courts decline even to try, counting on
juries (or, more likely, settlements) to do their work for them.
The Mirena court displayed rare dedication to the
principle that the system can work only if courts properly
discharge their duties as "gatekeepers." We applaud this
decision, urge you to read it and cite it, and we hope that more
courts will accept similar challenges. We will keep you posted.

This article is presented for informational purposes only
and is not intended to constitute legal advice.

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